Atherosclerosis Cardiovascular DiseaseMEDIVORENCT07462871
Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation and Cardiometabolic Health
A study testing Carnivore Diet and Mediterranean Diet in people with Atherosclerosis Cardiovascular Disease and Metabolic Syndrome, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis Cardiovascular Disease, Metabolic Syndrome, Dyslipidaemia
- What is being tested?
- Carnivore Diet and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- 30-60 years of age
- Elevated LDL cholesterol (LDL >3mmol/L and/or non-HDL cholesterol > 4mmol/L)
- Not following any specific diet for health reasons.
- Not currently taking lipid-lowering medications or supplements that may interfere with LDL levels.
Who cannot join
- Pregnancy or breastfeeding.
- Known food allergies or intolerances.
- Previous history of disordered eating.
- Currently taking cholesterol-lowering medication or supplements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Richie Kirwan contact
United Kingdom1 site
Tom Reilly Building, Liverpool John Moores University
Liverpool, L3 3AF
Megan Megan Wilson, 447362317430, M.L.Wilson@ljmu.ac.uk
Dr Richie Kirwan, R.P.Kirwan@ljmu.ac.uk
About this study
Official title: Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation Susceptibility and Cardiometabolic Health
The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol.
The main questions it aims to answer are:
Read more
- Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)?
- Do these two diets have different effects on other measures of heart and metabolic health, such as blood fats, blood vessel function, and overall wellbeing?
Researchers will compare people who follow the Mediterranean-style diet with those who follow the Carnivore-style diet to see which diet produces more beneficial changes in cholesterol and heart health markers.
Participants will:
- Attend three visits at Liverpool John Moores University for screening and data collection.
- Be randomly assigned to follow either the Mediterranean or Carnivore diet for 3 weeks, matched for calories and protein.
- Provide fasting blood, urine, and stool samples before and after the diet period.
- Complete non-invasive cardiovascular tests to measure blood vessel and heart function.
- Take part in a short interview and complete questionnaires about their experience of following the diet.
- Being tested
- Carnivore Diet, Mediterranean Diet
- Keywords
- Atherosclerosis, ASCVD, Diet, carbohydrate-restricted, Ketogenic diet, LDL aggregation, Low-density lipoproteins, Lipoproteins, Lipid metabolism
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carnivore DietDietary supplement
The intervention diet will consist of isocaloric consumption of exclusively of animal-based products, including red meat, poultry, and limited amounts of dairy products for 3 weeks. The diet will exclude plant-based foods, such as fruits, vegetables, grains, legumes, nuts, and seeds to reflect a traditional Carnivore-style dietary pattern.
Mediterranean DietDietary supplement
The intervention diet will consist of isocaloric consumption of foods typical of a traditional Mediterranean dietary pattern, including fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, for a period of 3 weeks. The diet will include moderate amounts of poultry and dairy products and limited amounts of red and processed meat, refined carbohydrates, and added sugars.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean-style diet | Active comparator | Participants will be provided with an isocaloric diet rich in fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, consistent with and optimised to reflect a traditional Mediterranean dietary pattern. The diet will include moderate amounts of poultry and dairy products and limited amounts of red and processed meat, refined carbohydrates, and added sugars. Receives: Dietary Supplement: Mediterranean Diet |
| Carnivore-style diet | Experimental | Participants will be provided with an isocaloric diet consisting primarily of animal-based products, including red meat, poultry, and limited amounts of dairy products. The diet will exclude plant-based foods, such as fruits, vegetables, grains, legumes, nuts, and seeds to reflect a traditional Carnivore-style dietary pattern. Receives: Dietary Supplement: Carnivore Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL aggregation susceptibility
To measure changes in how easily LDL cholesterol particles 'clump' together in the blood vessels from baseline to post-intervention, assessed via plasma lipid and lipoprotein analysis.
Measured: Baseline and 3 weeks.
Secondary outcomes (2)
Plasma lipid and lipoprotein profile
Changes in plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides will be determined via enzymatic analysis and measured in mmol/L.
Measured: Baseline and 3 weeks.
Lipoprotein particle size
Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.
Measured: Baseline and 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Wihuri Research Institute, University of Helsinki
- Responsible party
- Principal investigator, Megan Wilson, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462871
- Sponsor's protocol ID
- SLNMWILSRCT
- Acronym
- MEDIVORE
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team intends to consider sharing de-identified individual participant data after publication of the primary results, subject to participant consent, ethical approval, and institutional data governance review. A formal IPD sharing plan will be developed in collaboration with Liverpool John Moores University once data has been fully analysed.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation Susceptibility and Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT07462871
- Acronym / sponsor ID
- MEDIVORE / SLNMWILSRCT
- Keywords
- Atherosclerosis, ASCVD, Diet, carbohydrate-restricted, Ketogenic diet, LDL aggregation, Low-density lipoproteins, Lipoproteins, Lipid metabolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Wihuri Research Institute, University of Helsinki
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol.
The main questions it aims to answer are:
- Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)?
- Do these two diets have different effects on other measures of heart and metabolic health, such as blood fats, blood vessel function, and overall wellbeing?
Researchers will compare people who follow the Mediterranean-style diet with those who follow the Carnivore-style diet to see which diet produces more beneficial changes in cholesterol and heart health markers.
Participants will:
- Attend three visits at Liverpool John Moores University for screening and data collection.
- Be randomly assigned to follow either the Mediterranean or Carnivore diet for 3 weeks, matched for calories and protein.
- Provide fasting blood, urine, and stool samples before and after the diet period.
- Complete non-invasive cardiovascular tests to measure blood vessel and heart function.
- Take part in a short interview and complete questionnaires about their experience of following the diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean-style diet | Active comparator | Dietary Supplement: Mediterranean DietParticipants will be provided with an isocaloric diet rich in fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, consistent with and optimised to reflect a traditional Mediterranean dietary pattern. The diet will include moderate amounts of poultry and dairy products and limited amounts of red and processed meat, refined carbohydrates, and added sugars. |
| Carnivore-style diet | Experimental | Dietary Supplement: Carnivore DietParticipants will be provided with an isocaloric diet consisting primarily of animal-based products, including red meat, poultry, and limited amounts of dairy products. The diet will exclude plant-based foods, such as fruits, vegetables, grains, legumes, nuts, and seeds to reflect a traditional Carnivore-style dietary pattern. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female
- 30-60 years of age
- Elevated LDL cholesterol (LDL >3mmol/L and/or non-HDL cholesterol > 4mmol/L)
- Not following any specific diet for health reasons.
- Not currently taking lipid-lowering medications or supplements that may interfere with LDL levels.
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding.
- Known food allergies or intolerances.
- Previous history of disordered eating.
- Currently taking cholesterol-lowering medication or supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carnivore DietThe intervention diet will consist of isocaloric consumption of exclusively of animal-based products, including red meat, poultry, and limited amounts of dairy products for 3 weeks. The diet will exclude plant-based foods, such as fruits, vegetables, grains, legumes, nuts, and seeds to reflect a traditional Carnivore-style dietary pattern. | Dietary supplement | Carnivore-style diet |
| Mediterranean DietThe intervention diet will consist of isocaloric consumption of foods typical of a traditional Mediterranean dietary pattern, including fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, for a period of 3 weeks. The diet will include moderate amounts of poultry and dairy products and limited amounts of red and processed meat, refined carbohydrates, and added sugars. | Dietary supplement | Mediterranean-style diet |
Primary outcome
LDL aggregation susceptibility
Time frame: Baseline and 3 weeks.
To measure changes in how easily LDL cholesterol particles 'clump' together in the blood vessels from baseline to post-intervention, assessed via plasma lipid and lipoprotein analysis.
2 secondary outcomes
Plasma lipid and lipoprotein profile
Time frame: Baseline and 3 weeks.
Lipoprotein particle size
Time frame: Baseline and 3 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided. The research team intends to consider sharing de-identified individual participant data after publication of the primary results, subject to participant consent, ethical approval, and institutional data governance review. A formal IPD sharing plan will be developed in collaboration with Liverpool John Moores University once data has been fully analysed.
Related trials for Atherosclerosis Cardiovascular Disease
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Qatar Cardiometabolic Cohort
Cardiometabolic Diseases
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Richie Kirwan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carnivore Diet and Mediterranean Diet in people with Atherosclerosis Cardiovascular Disease and Metabolic Syndrome, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Wilson, BSc Nutrition (+447362317430, M.L.Wilson@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL aggregation susceptibility (time frame: Baseline and 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.